Bachmann&#39;s bundle electrode for atrial defibrillation

ABSTRACT

An implantable system for the defibrillation of the atria of a patient&#39;s heart comprises (a) a first catheter configured for insertion into the right atrium of the heart; a first atrial defibrillation electrode carried by the first catheter and positioned to stimulate Bachmann&#39;s bundle, or positioned at the atrial septum of the heart (i.e., an atrial septum electrode); (b) a second atrial defibrillation electrode which together with the first atrial defibrillation electrode provides a pair of atrial defibrillation electrodes that are configured for orientation in or about the patient&#39;s heart to effect atrial defibrillation, and (c) a pulse generator operatively associated with the pair of atrial defibrillation electrodes for delivering a first atrial defibrillation pulse to the heart of the patient. The second electrode may be configured for positioning through the coronary sinus ostium and in the coronary sinus or a vein on the surface of the left ventricle, such as the great vein. An additional electrode configured for positioning in the superior vena cava, right atrium (including the right atrial appendage, or the right ventricle may also be included, and the pulse generator may be configured or programmed for concurrently delivering a first defibrillation pulse through the additional electrode and the atrial septum electrode, and a second defibrillation pulse through the atrial septum electrode and the second electrode. Electrode assemblies and methods useful for carrying out the invention are also disclosed.

RELATED APPLICATIONS

This application is a continuation-in-part of U.S. patent applicationSer. No. 09/827,535, filed Apr. 6, 2001, which in turn claims thebenefit U.S. provisional application Ser. No. 60/196,722, filed Apr. 13,2000, the disclosures of both of which are incorporated by referenceherein in their entirety.

GOVERNMENT SUPPORT

This invention was made with Government support under National Instituteof Health grant HL-42760. The Government has certain rights to thisinvention.

FIELD OF THE INVENTION

This invention relates to methods, apparatus, and catheters that may beused to administer a therapeutic electrical pulse, such as an atrialdefibrillation pulse, to the heart of a patient in need of suchtreatment.

BACKGROUND OF THE INVENTION

Atrial fibrillation (AF) is the most common arrhythmia in humans andrepresents a significant public health problem. There are presently 2.2million cases of AF in the United States and approximately 160,000 newcases diagnosed each year. AF is typically managed by a combination ofanti-arrhythmic drugs and external or internal electrical cardioversion.In addition, surgical compartmentalization or radiofrequency ablation ofatrial tissue can be used. Unfortunately, long term success rates arelow; AF recurrence is high with both drug treatment and electricalcardioversion with internal and external shocks.

Internal electrical cardioversion of AF remains an uncomfortable therapyoption for managing patients with AF. Even with recent advancements,shock voltages necessary to defibrillate the atrial, while considerablylower than that for the ventricles, are still beyond the painthreshhold. One reason high voltages may be necessary is that the maingenerator for AF is the left atrium and direct access to the left atriumis problematic because of the risk of embolism. Typically, atrialdefibrillation lead locations are limited to right sided chambers (rightatrium and right ventricle) and venous structures accessible from theright side of the heart (coronary sinus).

To create a trans-atrial shocking vector, the most common approach is toshock between one or more electrodes on the right side of the heart(right atrial appendage, superior vena cava, or right ventricle) to anelectrode on the left side of the heart in the distal coronary sinus.The left atrium is also an important atrial chamber to defibrillatesince (i) it can fibrillate independent of the right atrium, (ii)mapping studies have shown that earliest sites of activation followingfailed defibrillation arise from the left atrium for most defibrillationelectrode configurations, (iii) early sites in or near the pulmonaryveins have been shown to be responsible for the initiation of and earlyreoccurence of AF in many patients, and (iv) ablation of right atrialstructures alone has had poor success in terminating AF or preventingits reoccurence. Nevertheless, there remains a need for means ofdefibrillating the atria of a subject without unduly high energydefibrillation pulses that would be painful to the subject beingtreated.

SUMMARY OF THE INVENTION

A first aspect of the present invention is an implantable system for thedefibrillation of the atria of a patient's heart. The system comprises(a) a first catheter configured for insertion into the right atrium ofthe heart (in one embodiment preferably without extending into the rightventricle of the heart); a first atrial defibrillation electrode carriedby the first catheter and positioned at Bachmann's bundle or at theatrial septum of the heart (i.e., a Bachmann's bundle or an atrialseptum electrode); (b) a second atrial defibrillation electrode whichtogether with the first atrial defibrillation electrode provides a pairof atrial defibrillation electrodes that are configured for orientationin or about the patient's heart to effect atrial defibrillation, and (c)a pulse generator operatively associated with the pair of atrialdefibrillation electrodes for delivering a first atrial defibrillationpulse to the heart of the patient. The second electrode may beconfigured for positioning through the coronary sinus ostium and in thecoronary sinus or a vein on the surface of the left ventricle, such asthe great vein. As explained further below, an additional electrodeconfigured for positioning in the superior vena cava, right atrium(including the right atrial appendage, or the right ventricle may alsobe included, and the pulse generator may be configured or programmed forconcurrently delivering a first defibrillation pulse through theadditional electrode and the atrial septum electrode, and a seconddefibrillation pulse through the atrial septum electrode and the secondelectrode.

A second aspect of the present invention is a catheter assembly usefulfor the defibrillation or cardioversion of a patient's heart. Theassembly comprises: (a) a first transveneous catheter configured forinsertion into the heart of the patient, the first transvenous catheterhaving a proximal end portion, a distal end portion, and an elongateintermediate portion therebetween, and with the first transveneouscatheter having a first electrode connected thereto; (b) a secondtransveneous catheter configured for insertion into the heart of thepatient, the second transveneous catheter having a proximal end portion,a distal end portion, and an elongate intermediate portion therebetween;and (c) a connecting member attached to the first transveneous catheter,with the connecting member connected to the second transveneous catheterintermediate portion.

A further aspect of the present invention is a method for thedefibrillation or cardioversion of the heart of a patient in needthereof while minimizing or reducing the voltage of the defibrillationpulses to be delivered. The method comprises the steps of: (a)positioning first and second defibrillation electrodes in operableassociation with the heart of the subject, the first and seconddefibrillation electrodes defining a gradient field in the heart, thegradient field including a region of the heart to be defibrillated; (b)positioning a third electrode in the gradient field between the firstand second electrodes; and then (c) concurrently delivering (i) a firstdefibrillation pulse between the first and third electrode and (ii) asecond defibrillation pulse between the second and third electrodes;with the first and second defibrillation pulses together effective todefibrillate the heart. The voltage required for each of the first andsecond defibrillation pulses is preferably less than the voltagenecessary for a single defibrillation pulse delivered between the firstand second electrodes that is effective to defibrillate the heart. One,two or three or more additional electrodes may be positioned between thefirst, second and third electrodes to further reduce the voltagerequired, with additional shocks being delivered concurrently betweenvarious combinations of the electrodes (typically between adjacentelectrodes).

A further aspect of the present invention is an implantable system forthe defibrillation or cardioversion of a patient's heart. The systemcomprises: (a) first and second defibrillation electrodes configured forpositioning in operable association with the heart of the subject, thefirst and second defibrillation electrodes when so positioned defining agradient field in the heart between the first and second electrodes andin a region to be defibrillated; (b) a third defibrillation electrodeconfigured for positioning in the gradient field between the first andsecond electrodes; and (c) a pulse generator operatively associated withthe first, second and third defibrillation electrodes and configured forconcurrently delivering (a) a first defibrillation pulse between thefirst and third electrode and (b) a second defibrillation pulse betweenthe second and third electrodes. The two pulses are together effectiveto defibrillate the heart. Preferably, the voltage required for each ofthe first and second defibrillation pulses is less than the voltagerequired for a single defibrillation pulse delivered between the firstand second electrodes that is effective to defibrillate the heart. Suchan apparatus may be configured to carry out the methods described above.

In preferred embodiments of the foregoing methods and systems, there isfurther provided first and second transveneous catheters, wherein thefirst, second and third electrodes are carried by the first and secondtransveneous catheters, and wherein the first transveneous catheter isfixed to the second transveneous catheter.

In particularly preferred embodiments of the foregoing methods andsystems, the first and second electrodes are carried by a firsttransveneous catheter, the first transveneous catheter having a proximalend portion, a distal end portion, and an elongate intermediate portiontherebetween. The third electrode is carried by a second transveneouscatheter, the second transveneous catheter having a proximal endportion, a distal end portion, and an elongate intermediate portiontherebetween. The second transveneous catheter distal end portion isconnected to the first transveneous catheter intermediate portionthrough a connecting member, as described in connection with catheterassemblies above. The third electrode is then, preferably, an atrialseptum electrode.

A further aspect of the present invention is an implantable system forthe electrical treatment/defibrillation of the atria of a patient'sheart, the system comprising: a first atrial therapeutic electrodeconfigured for stimulating Bachmann's bundle and for positioning on oradjacent Bachmann's bundle along the superior aspect of the atrium andadjacent to the atrial septum; a second atrial electrode which togetherwith the first atrial electrode provides a pair of atrial electrodes;and a pulse generator operatively associated with the pair of atrialelectrodes for delivering an atrial defibrillation or other therapeuticpulse. Methods of delivering an atrial defibrillation pulse, or othertherapeutic pulse, by positioning electrodes as described above are afurther aspect of the invention. The first atrial electrode may becarried by a first catheter, with the first catheter configured forinsertion into the right atrium of the heart, preferably withoutextending into the right ventricle of the heart. The second atrialelectrodes may be positioned as described in connection with secondelectrodes corresponding to or paired with atrial septum electrodes asdescribed herein.

A further aspect of the present invention is a method for the electricaltreatment or defibrillation of the atria of a patient's heart,comprising the steps of: providing a set of atrial therapeuticelectrodes for defibrillating the patient's heart, or otherwiseadministering a therapeutic electric pulse to the patients heart, theset including a first atrial electrode positioned in the superior venacava of the patient; delivering a first therapeutic electric pulse suchas a defibrillation pulse to the atria of the heart, and then deliveringa second therapeutic electric pulse such as a defibrillation pulse pulseto the atria of the heart, wherein at least one of the first and secondpulses is delivered with the first atrial defibrillation electrode. Setsof atrial therapeutic or defibrillation electrodes that may be used tocarry out this method include but are not limited to the sets of atrialdefibrillation electrodes described herein. For example, the set ofatrial electrodes may further comprise a second atrial therapeutic ordefibrillation electrode positioned in the coronary sinus of the heart,and at least one of the first and second pulses may be delivered withthe second atrial electrode. In one embodiment, at least one of thefirst and second therapeutic pulses is delivered between the first andsecond therapeutic electrodes.

A further aspect of the present invention involves the balancing of peakamplitudes for defibrillating the atria or ventricles of a patient'sheart, or otherwise delivering a therapeutic electric pulse to the atriaor ventricles of a patient's heart. The method comprises: delivering afirst therapeutic electrical pulse such as a defibrillation pulse to theatria or ventricles of the heart, and then delivering a secondtherapeutic electric pulse such as a defibrillation pulse to the atriaor ventricles of the heart, wherein the total energy, or leading edgepeak voltage, of the second pulse is at least 90 or 95% of the totalenergy, or leading edge peak voltage, of the first pulse. Sets oftreatment electrodes that may be used to carry out this method includebut are not limited to the sets of atrial treatment electrodes describedherein. An apparatus configured to carry out this method (e.g.,employing two separate discharge capacitors operatively associated witha power supply and a controller, with the controller configured so thatthe first capacitor is discharged by the controller to administer thefirst pulse and the second capacitor is discharged by the controller toadminister the second pulse; or with a single capacitor havingsufficient storage capacity so that the aforesaid energy or voltagefeatures can be achieved through wave shaping through the controller) isa further aspect of the invention.

A still further aspect of the present invention is a transveneouscatheter for stimulating the heart of a patient at separate locationstherein, the catheter comprising: a catheter body having a proximalportion, an intermediate portion and a distal portion; a first electrodeconnected to the catheter body distal portion; a catheter appendagehaving a proximal portion and a distal portion, the appendage proximalportion connected to the catheter body intermediate portion; and asecond electrode connected to the appendage distal portion. In oneembodiment of the foregoing, the catheter body is configured forinsertion into the right ventricle of the heart. In a particularembodiment of the foregoing, the catheter body is configured forinsertion through the coronary sinus ostium and into the coronary sinusof the heart. The second electrode of the catheter may be an aterialelectrode, such as an atrial septum electrode or a Bachmann's bundleelectrode.

The foregoing and other objects and aspects of the present invention areexplained in greater detail in the drawings herein and the specificationset forth below.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 illustrates a first embodiment of an implantable system of thepresent invention, in which the atrial septum electrode is atrans-septal electrode. The heart is shown in partial cut-away view,with the right atrium, the right ventricle, and a portion of the leftatrium being shown in cross section. The surface of the left ventricleis shown so that vessels on the surface of the ventricle that areaccessed through the coronary sinus (shown in dashed lines) may be seen.

FIG. 2 illustrates a second embodiment of an implantable system of thepresent invention, in which the atrial septum electrode is fixed to theatrial septum by means of a terminal screw.

FIG. 3 illustrates a third embodiment of an implantable system of thepresent invention, in which the atrial septum electrode is incorporatedinto an expandable umbrella device which is opened within the rightatrium to hold the electrode against the atrial septum.

FIG. 4 illustrates a fourth embodiment of an implantable system of thepresent invention, in which the atrial septum electrode is fixed to thecoronary sinus electrode to form a catheter assembly and facilitate theholding of the atrial septum electrode against the atrial septum.

FIG. 5 illustrates a catheter assembly as used in FIG. 4, in which thefirst catheter is permanently fixed to the second catheter.

FIG. 6 illustrates an alternate embodiment of a catheter assembly of thepresent invention, in which the first catheter is releasably fixed tothe second catheter by means of a retractable loop.

FIG. 7 illustrates a further alternate embodiment of a catheter assemblyof the present invention, in which the first catheter is releasablyfixed to the second catheter by means of an elastic loop.

FIG. 8 illustrates a still further alternate embodiment of a catheterassembly of the present invention, in which the connecting member ispositioned on an intermediate portion rather than the distal portion ofthe first catheter.

FIG. 9 illustrates a still further alternate embodiment of animplantable system incorporating a catheter assembly of the presentinvention, in which the second catheter extends into the right ventricleand is fixed to the apex of the right ventricle by means of a terminalscrew.

FIG. 10 illustrates a further embodiment of a catheter assembly of thepresent invention, in which the second catheter includes an expandablestent to further anchor the second catheter within a suitable vessel,such as a pulmonary artery.

FIGS. 11A-C schematically illustrate a technique for lowering shockvoltage that may be used in conjunction with the instant invention orother defibrillation techniques.

FIG. 12 schematically illustrates a technique for lowering ventriculardefibrillation voltage that implements the technique illustrated inFIGS. 11A-C.

FIG. 13 shows the ADFT leading edge voltage in experimental animals usedto demonstrate the instant invention. The leading edge voltage ofconfiguration A2 is significantly lower than the others (number showsthe percent lower).

FIG. 14 shows the ADFT leading edge current in experimental animals usedto demonstrate the instant invention. The leading edge current ofconfiguration A2 is significantly lower than the others (number showsthe percent lower).

FIG. 15 shows the ADFT total shock energy in experimental animals usedto demonstrate the instant invention. The shock energy of configurationA2 is significantly lower than the others (number shows the percentlower).

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

The present invention is explained in greater detail below. Thisdescription is not intended to be a detailed catalog of all thedifferent ways in which the invention may be implemented, or all thefeatures that may be added to the instant invention. For example,features illustrated with respect to one embodiment may be incorporatedinto other embodiments, and features illustrated with respect to aparticular embodiment may be deleted from that embodiment. In addition,numerous variations and additions to the various embodiments suggestedherein will be apparent to those skilled in the art in light of theinstant disclosure which do not depart from the instant invention.Hence, the following specification is intended to illustrate someparticular embodiments of the invention, and not to exhaustively specifyall permutations, combinations and variations thereof.

The terms “atrial septum electrode” or electrode positioned “at theatrial septum”, as used herein, refer to an electrode that is, or isconfigured to be, inserted through the atrial septum (i. e., atrans-septal electrode), inserted into the atrial septum (i.e., insertedpartially into the septum without penetrating completely through theseptum), or substantially contacted to the surface of the atrial septum(typically the surface facing the right atrium). An atrial septumelectrode may also be an electrode that is directly or indirectlysecured to the atrial septum, but is spaced up to about 1, 2, or 4millimeters or more away from the septum, where the electric fieldproduced from the electrode is effective in stimulating the atrialseptum in substantially the same manner as an electrode inserted into orcontacting to the atrial septum. Patients treated by the methods of thepresent invention are typically human.

“Bachmann's bundle” as used herein refers to a transverse band of musclefibers on the roof of the atria, immediately adjacent to or lying alongside of the atrial septum.

The term “catheter” is used interchangeably with “lead” herein, and isnot meant to imply that the particular structure has an interior lumenfor receiving a guide wire or the like, as such a lumen is optional incarrying out the present invention, and the use of one or moreguidewires is optional in carrying out the present invention.

The term “concurrently”, when used herein with respect to two or moredefibrillation pulses, refers to pulses that are administeredsufficiently close in time so that the combined therapeutic effect isgreater than the sum of the therapeutic effects when the pulses areadministered singly. Such pulses may be administered simultaneously,partially overlapping in time, or sequentially in time. Whenadministered sequentially in time the pulses may or may not have anintervening time period therebetween. Preferably, the onset of asubsequent pulse occurs within 100, 200 or 500 milliseconds of theoffset of a preceding pulse.

The term “defibrillation pulse” is used herein to encompass any of avariety of defibrillation, or cardioversion, waveforms. The particulartype of pulse delivered is not critical and may, for example, comprise:a monophasic or biphasic waveform; a pulse that includes a series ofwaveforms; waveforms that are uniform, stepped, saw-toothed, truncatedexponential, etc.

The term “pulse generator” as used herein is intended to encompass anytype of device, preferably contained within an implantable housing toform an implantable cardioverter defibrillator (ICD), that delivers thedefibrillation pulse or pulses desired to achieve a particular method.In general, such pulse generators comprise a battery power supply, acontrol circuit, and a capacitor (or capacitor circuit). The controlcircuit is connected to the battery and the capacitor for charging thecapacitor and delivering a therapeutic defibrillation pulse from thecapacitor through the defibrillation electrodes. The control circuittypically includes a detection circuit for monitoring the heart of asubject and determining when the capacitor should be charged and atherapeutic pulse delivered. Numerous additional features may beincluded, as is known to those skilled in the art.

A. Atrial Septum Electrodes for Atrial Defibrillation

As noted above, the present invention provides an implantable system forthe defibrillation of the atria of a patient's heart. Such a systemtypically comprises a first catheter configured for insertion into theright atrium of the heart; a first atrial defibrillation electrodecarried by the first catheter and positioned at the atrial septum of theheart; a second atrial defibrillation electrode which together with thefirst atrial defibrillation electrode provides a pair of atrialdefibrillation electrodes that are configured for orientation in orabout the patient's heart to effect atrial defibrillation, and a pulsegenerator operatively associated with the pair of atrial defibrillationelectrodes for delivering a first atrial defibrillation pulse to theheart of the patient. It will be appreciated that the atrial septumelectrode need not be used in conjunction with every pulse or shockdelivered by the system and methods as long as it used in some of thepulses or shocks delivered by the system and methods.

FIG. 1 illustrates a first embodiment of an implantable system of thepresent invention. The heart 20 is shown in partial cut-away view, withthe right atrium 21, the right ventricle 22, and a portion of the leftatrium 23 being shown in cross section. The surface of the leftventricle 24 is shown so that veins or vessels 25 on the surface of theventricle that are accessed through the coronary sinus 26 (shown indashed lines) and the coronary sinus ostium 27 may be seen. A pair ofcatheters 30, 31, enter the heart through the superior vena cava 28. Onecatheter is positioned through a trans-septal puncture formed in theatrial septum so that the atrial septal electrode 32 that is connectedto that catheter extends through the septum. An introducer sheath,needle, or the like may be used to form the puncture and introduce theelectrode therethrough, as will be apparent to those skilled in the art.The other catheter extends through the ostium of the coronary sinus andthrough the coronary sinus and into a vessel on the surface of the leftventricle of the heart (e.g., the great vein), where an additionaldefibrillation electrode 33 connected to that catheter is positioned.

The system includes an implantable cardioverter defibrillator (ICD) 40comprises a housing 41 containing a pulse generator 42, with asubcutaneous electrode 43 located on the external surface of the housingas described in U.S. Pat. No. 5,292,338 to Bardy. The defibrillator isthen implanted in the left or right (preferably left) thoracic region ofthe patient (e.g., subcutaneously, in the left pectoral region, inaccordance with known techniques. The housing electrode 43 may be usedin conjunction with or in alternative to other catheter mountedelectrodes.

Sensing of atrial fibrillation for triggering of a defibrillation can becarried out through any suitable means, and may employ the sameelectrodes that are used for defibrillation or separate sensingelectrodes. In the alternative, the defibrillation pulse may, ifdesired, be triggered manually or externally by an operator or thepatient. It will be appreciated that a sensing electrode (not shown)will also preferably be provided in the right ventricle, e.g. on aseparate catheter, to sense the ventricular cycles and deliver thisinformation to the pulse generator so that the pulse generator deliversthe atrial defibrillation pulse or pulses at a time when ventricularfibrillation is not likely to be induced thereby, as is known in theart.

While the atrial septum electrode is primarily described herein for thedelivery of atrial defibrillation or cardioversion pulses, it will beappreciated that the system can be configured to carry out other usefulmethods from the atrial septum electrode. For example, an atrial septumelectrode can be used to deliver pacing pulses from the pulse generatorprior to the onset of atrial fibrillation to reduce the chance of atrialfibrillation occuring. In addition, an atrial septum electrode can beused to deliver pacing pulses after the onset of atrial fibrillation,but before a defibrillation pulse is delivered, in an effort to avoidthe need to deliver a defibrillation pulse. If fibrillation continuesafter the pacing pulse is delivered, then a defibrillation pulse can bedelivered. The atrial septum electrode used to deliver such pacingpulses may be the same or different from the atrial septum electrodeused to deliver defibrillation pulses (e.g., multiple adjacent atrialseptum electrodes may be provided on a single catheter).

FIG. 2 illustrates a second embodiment of an implantable system of thepresent invention. This system again comprises an implantable ICD 50, apair of catheters 51, 52, an atrial septum defibrillation electrode 54,and an additional defibrillation electrode 55 in the great vein. Theatrial septum electrode is fixed to the atrial septum by a terminalscrew or helix 56 connected to the distal end portion of catheter 51,which penetrates partially into (or all the way through) the atrialseptum. Of course, any suitable connecting means may be employed inaddition to a terminal screw or helix, including but not limited to aretractable hook connected to the distal end portion of the catheter 51.

FIG. 3 illustrates a third embodiment of an implantable system of thepresent invention, again including an implantable ICD 70, a pair ofcatheters 71, 72, and a defibrillation electrode 73 positioned in thegreat vein. The atrial septum electrode 74 is incorporated into anexpandable device or element 75 which is opened within the right atrium(or allowed to open within the atrium by removal of an introducer sheathor the like) to hold the electrode 76 against the atrial septum byexpanding to a size about the same as or slightly greater than theinterior diameter of the right atrium and forcing the electrode againstthe atrial septum. In the alternative, an expandable element could beused in conjunction with a helix, screw, hook or other fixing meanslocated on the distal tip of the catheter to unfold the electrode into aconfiguration contacting the atrial septum, to thereby provide bettercontact or expanded contact area of the defibrillation electrode againstthe atrial septum.

FIG. 4 illustrates a particularly preferred embodiment of an implantablesystem of the present invention, in which the catheter 90 carrying theatrial septum electrode 91 is fixed to the catheter 92 carrying coronarysinus electrode 93 to form a catheter assembly and facilitate theholding of the atrial septum electrode against the atrial septum. Thesystem includes an ICD 94, which again may incorporate features such asdescribed in connection with ICDs as set forth above. A connectingmember 95, typically located at the distal end portion of the firstcatheter and connected to the intermediate portion of the secondcatheter, is included for interconnecting the two catheters. Such aconfiguration or assembly, in addition to being particularly suitablefor carrying out the present invention has a variety of differentapplications, and is discussed in greater detail in section B below.

B. Catheter Assembly with Fixation of One Catheter to Another

The present invention provides a catheter assembly useful for thedefibrillation or cardioversion of a patient's heart, of which theassembly illustrated in FIG. 4 is one example. As noted above, suchassemblies typically comprise a first transveneous catheter configuredfor insertion into the heart of the patient, the first transvenouscatheter having a proximal end portion, a distal end portion, and anelongate intermediate portion therebetween. The first transveneouscatheter typically has a first electrode connected thereto. The firstelectrode is typically connected to the first transveneous catheterintermediate portion, although it will be noted that the intermediateportion is quite elongate and the first electrode may be positionedanywhere along the length thereof.

A second transveneous catheter configured for insertion into the heartof the patient is also included in the assembly, the second transveneouscatheter also having a proximal end portion, a distal end portion, andan elongate intermediate portion therebetween. The second catheter may,for example, be configured for positioning in a suitable location, suchas into the right ventricle, optionally extending to the apex of theright ventricle, through the ostium of the coronary sinus and into orthrough the coronary sinus, etc. The assembly further includes aconnecting member attached to the first transveneous catheter (e.g., atthe distal end portion or at the proximal portion thereof), with theconnecting member connected to the second transveneous catheterintermediate portion.

The second transveneous catheter generally has at least one electrodeconnected thereto (. e.g., an electrode for positioning in the coronarysinus or a vein on the surface of the left ventricle), which electrodemay be a therapeutic, or defibrillation, electrode, and/or a monitoringelectrode such as a ring electrode or tip electrode. However, the secondtransveneous catheter need not necessarily carry an electrode if itfunctions primarily to secure or anchor the first catheter in place.Hence, the second catheter may be referred to as an “anchoring catheter”or “positioning catheter”.

While such catheter assemblies may be used for atrial defibrillationsystems and methods as described herein, it is also envisioned that suchcatheter assemblies will find a variety of additional applications, suchas for ventricular defibrillation or cardioiversion, whenever it isdesirable to securely fix a particular catheter in place.

FIG. 5 illustrates a catheter assembly 110 of the present invention,which may be configured in any suitable manner including but not limitedto that shown in FIG. 4. The assembly comprises a first catheter 111having a proximal end portion, 112, a distal end portion 113, and anelongate intermediate portion 114 therebetween. Note that proximal endportions will typically terminate in a connector (not shown) tofacilitate mechanical connection of the catheters to the ICD andelectrical connection of the electrodes to the pulse generator containedtherein. A first defibrillation electrode 115 is connected to theintermediate portion 114. A connecting member 116 is connected to thedistal end portion 113 of the first catheter, and is permanently fixedto the second catheter 118 (e.g, by permanently fastening two separatemembers; by integrally forming the two members together). Secondcatheter 118 also has a proximal end portion 119, a distal end portion120, and an intermediate portion 121, with a defibrillation electrode122 positioned proximal to the connecting member and a furtherdefibrillation electrode 123 positioned distal to the connecting member.As noted above, either or both of the electrodes on the second catheterare optional, and additional electrodes such as sensing electrodes couldbe included if desired.

FIG. 6 illustrates an alternate embodiment of a catheter assembly 130 ofthe present invention, in which the first catheter 131 is releasablyfixed to second catheter 132 by means of a retractable loop 133. Anysuitable means can be used to retract the loop, such as the insertion ofa tendon 134 through a lumen in catheter 131 which connects to the loop,and which can be drawn back to tighten the loop. As with any other suchreleasably secured connecting member, the loop can be fastened around anintermediate portion 135 of the catheter assembly at any of a variety oflocations to optimally configure the electrode assembly for a particularpatient. The intermediate portion 135 can be substantially smooth asillustrated, or may be textured or the like to enhance fastening of theloop to the catheter and reduce lateral slippage along the length of thesecond catheter intermediate portion. If desired, an introducer sheath(not shown) can be deployed around the second catheter and used to pushthe loop forward down the second catheter until the desired location isachieved (e.g., just outside or proximal to the coronary sinus ostium,when the second catheter is inserted through the ostium), with the loopthen being tightened and the introducer sheath removed. In thealternative, an introducer can be used to carry the second catheter tothe desired position rather than push the connecting member to thedesired position.

FIG. 7 illustrates a further alternate embodiment of a catheter assembly150 of the present invention, in which the first catheter 151 isreleasably fixed to the second catheter 152 by means of an elastic loop153. The elastic loop may be formed of any suitable polymeric material,metallic material or the like that is sufficiently resilient to allowits deformation and reformation around the second catheter (and, ifnecessary, around the first catheter). The distal end portion 154 of thefirst catheter is enlarged to reduce the chance of the resilient loopslipping off the tip thereof (or, in the alternative or in additionthereto, the resilient loop could be permanently fastened to the firstcatheter). As in the embodiment of FIG. 6, an introducer sheath may bedeployed around the second catheter to push the elastic loop to theproper location around the second catheter. Again, texturing or the likecould be provided on the intermediate portion of the second catheter toreduce slippage along the length thereof.

In a variation to the embodiment described above in connection with FIG.7, the fastening loop 153 could be substantially inelastic, if thesecond and/or first catheter itself were sufficiently elastic to allowthe catheter to be forced therethrough, yet sufficiently resilient tosecure the catheters to the loop when forced to the desired location bymeans of an introducer sheath or the like.

FIG. 8 illustrates a still further embodiment of a catheter assembly 170of the present invention, in which the connecting member (a retractableloop 171 with a tendon 172 as illustrated) is positioned on anintermediate portion 173 of the first catheter 174 rather than thedistal portion of the first catheter as shown above. Any number ofelectrodes could be included in such an embodiment. As illustrated, thefirst catheter 174 has electrodes 175, 176 proximal and distal to theconnector, and the second catheter 178 has electrodes 180, 181 proximaland distal to the loop connector. Such an assembly could be used, forexample, to position electrode 180 in or through the coronary sinus,electrode 176 in the right ventricle, electrode 175 at the atrialseptum, and electrode 181 in the right atrium or superior vena cava.

FIG. 9 illustrates a still further alternate embodiment of animplantable system comprising an ICD 190, and a pair of catheters 191,192 configured as an assembly through a connector 193. Here the secondcatheter extends into the right ventricle and is fixed to the apex ofthe right ventricle by means of a terminal screw or helix 194. Any otherterminal fastening means, such as a retractable hook, could also beemployed.

FIG. 10 illustrates a further embodiment of a catheter assembly 210 ofthe present invention, comprising first and second catheters 211, 212,and in which the second catheter includes an expandable stent 213 thatis expanded or retracted by tendon 214 to further anchor the secondcatheter within a suitable vessel, such as a pulmonary artery. Such anadditional anchoring feature could be added as appropriate to any of theembodiments described above.

C. Location of Additional Electrodes to Lower Shock Voltage and EnergyRequired for Defibrillation

A further aspect of the present invention is a method for thedefibrillation or cardioversion of the heart of a patient in needthereof while minimizing the voltage of defibrillation pulses to bedelivered. As noted above, the method involves, first, positioning firstand second defibrillation electrodes in operable association with theheart of the subject, the first and second defibrillation electrodesdefining a gradient field in the heart, the gradient field including aregion of the heart to be defibrillated. Next, a third electrode (e.g.,an atrial septum electrode) is positioned in the gradient field betweenthe first and second electrodes. Then, a first defibrillation pulsebetween the first and third electrode and a second defibrillation pulsebetween the second and third electrodes are concurrently delivered, withthe first and second defibrillation pulses together effective todefibrillate the heart. The voltage required for each of the first andsecond defibrillation pulses is preferably less than the voltagenecessary for a single defibrillation pulse delivered between the firstand second electrodes that is effective to defibrillate the heart. Allof the electrodes may be carried on transveneous catheters, eitherseparately or with multiple electrodes on a single catheter.

Such a technique can be used for any of a variety of purposes, includingtreating patients afflicted with atrial fibrillation and patientsafflicted with ventricular fibrillation. For atrial fibrillation, eachof the first and second defibrillation pulses are preferably not greaterthan, and more preferably less than, 50, 100, or 150 volts in magnitude,and each of the first and second defibrillation pulses are preferablynot greater than, and more preferably less than, one, two or four Joulesin magnitude. Preferably, the gradient field created by the firstdefibrillation pulse and the second defibrillation pulse in the regionof the heart to be defibrillated is at least 3 or 4 volts percentimeter. The specific minimum potential gradient (which must becreated throughout all, or substantially all, of the fibrillatingmyocardium), differs for different defibrillation waveforms, but isthought to be in the range of approximatley 4 to 7 volts per centimeter,with at least about a 4 volt per centimeter gradient needed for a goodbiphasic defibrillation waveform.

FIGS. 11A-C schematically illustrates such a technique. Panel Aillustrates an original pair of electrodes (A and B) that create asubstantially even potential gradient field in the region between thetwo electrodes, with the gradient field including a region in the atriaor ventricles or the heart of a patient to be defibrillated. Assumingthat (1) the electrodes are 20 cm apart, (2) the conductivity of themedium is substantially uniform, and (3) there is no substantial voltageloss at the electrode-media interface, and (4) a 4 volt per centimeterpotential gradient must be created throughout the region, then a shockvoltage of about 80 volts will be required. Panel B shows a thirdelectrode (C) approximately half way between the original pair ofelectrodes (A,B). A shock between electrodes A and C will create apotential gradient of 4 volts per centimeter in the left half of theregion with a 40 volt shock. Similarly, a 40 volt shock betweenelectrodes C and B will create the desired 4 volt per centimeterpotential gradient throughout the right half of the region. If the twoshocks are given concurrently and are substantially the same duration asthe original shock through electrodes A and B, then the voltage of eachshock will be approximately half that of the original, while the totalenergy of the two shocks will be the same as that of the original shock.Therefore, the maximum voltage delivered to the heart of the patient inthis example will be about 40 volts rather than 80 volts.

More than three electrodes may be used to implement this technique. Forexample, panel C of FIG. 11 shows the addition of two additionalelectrodes (D and E). Concurrent (e.g., sequential) shocks through fourpairs of electrodes (A to D, D to C, C to E, and E to B) in varioussequences will again reduce the voltage in half to 20 volts whilemaintaining the same total energy.

When this technique is used for atrial defibrillation, such as with asystem and/or catheter assembly as illustrated in connection with FIGS.1-10 above, the method may comprise the steps of: (a) positioning afirst defibrillation electrode in the right atrium (including the rightatrial appendage), superior vena cava or right ventricle of the subject;(b) positioning a second defibrillation electrode in the coronary sinusor a vein on the surface of the left ventricle of the heart (e.g., thegreat vein); (c) positioning a third electrode at the atrial septum ofthe heart; and then (d) concurrently delivering (i) a firstdefibrillation pulse between the first and third electrode and (ii) asecond defibrillation pulse between the second and third electrodes.Preferably, each of the first and second defibrillation pulses has anenergy not greater than, or less than, one, two or four Joules,preferably each of the first and second defibrillation pulses has avoltage less than 50, 100 or 150 volts, preferably the first and seconddefibrillation pulses are delivered within 500 milliseconds of eachother, and preferably the gradient field created by each defibrillationpulse in the heart of the patient is greater than 4 volts percentimeter.

The foregoing method of reducing shock voltage may be implemented intechniques other than atrial defibrillation. For example, FIG. 12schematically illustrates a technique for lowering ventriculardefibrillation threshholds during open-chest cardiac surgery with anarray of three or more epicardial electrodes. The particular electrodearray of FIG. 12 is similar to the array of FIG. 11C. Such a systemdecreases the voltage needed for defibrillation in the operating room,which could decrease the damaging effects associated with largedefibrillation shocks. Since the electrodes in FIG. 12 are placed on theepicardium, they will not have as much effect on the shock potentialgradient field in the ventricular septum as they will in the ventricularfree walls. A modification of this system to increase the potentialgradient in the septum is, accordingly, to add an additional electrode(F) place in the right ventricular cavity against the inter-ventricularseptum, optionally as part of a catheter. Then, in addition to thevarious possible concurrent shock sequences through electrodes A to E,one or more shocks could be delivered from electrode F to some or all ofelectrodes A to E. Systems for implementing such methods can be providedwith the necessary electrodes operably associated with a pulse generatorconfigured or programmed to carry out the shock patterns describedherein in accordance with known techniques.

The implementation of the present invention in connection with aBachmann's bundle electrode is further illustrated in connection withFIGS. 16-18, where “RA” means right atrium, “RV” means right ventricle,“LA” means left atrium, “LV” means left ventricle, “SVC” means superiorvena cava, “CSos” means ostium of the coronary sinus, and “Distal CS”means distal coronary sinus. Therapeutic pulses and other electrodes maybe implemented as described above in connection with atrial septumelectrodes.

For example, as shown in FIG. 16, defibrillation may be carried out withtwo shocks or defibrillation pulse, with one of the shocks deliveredfrom an electrode 301 at the right atrium to the distal coronary sinus303, and the other delivered from an electrode 302 at Bachmann's bundle,near or adjacent the anterior-superior insertion of the atrial septum,to an electrode 304 in or adjacent the coronary sinus ostium (os), nearthe posterior-inferior insertion of the atrial septum. The electrode atthe os of the coronary sinus can be on the same catheter 305 thatcontains the electrode in the distal coronary sinus. The electrode atBachmann's bundle can be on its own lead 306. The right atrial electrodecan either be on its own lead, or on the lead passing into the coronarysinus.

The first of the two shocks can be either through the right atrial todistal coronary sinus electrodes or through the Bachmann's bundle tocoronary sinus os electrodes. The voltage of the second shock can be (1)equal to the trailing edge voltage of the first shock as from a singlecapacitor, (2) equal to the leading edge voltage of the first shock, aswould occur if each shock were delivered from a different capacitorcharged to the same voltage, or (3) with the voltage of the second shocksome other fraction of the voltage of the first shock, as could beperformed with two capacitors charged to different voltages. All threeof these cases can be delivered from a single capacitor bank by using anelectronic circuit to cause the voltages of the first and second shockto be the desired values. For example, atrial defibrillation with suchelectrode configurations may be carried out with less than 200 or 300volts, while the capacitor bank in an atrial-ventricular defibrillatorcan be charged to approximately 800 volts since this voltage is requiredfor ventricular fibrillation. An electronic control circuit can shapethe waveform delivered from the 800 voltcapacitor to be almost anydesired shape for two different shocks each of which are less than 200or 300 volts.

Note that the insertion of the superior vena cava into the right atriumis near Bachmann's bundle. Therefore another shock configuration is tosubstitute an electrode in the superior vena cava for the electrode atBachmann's bundle, e.g., to stimulate Bachmann's bundle. The advantageof this configuration for an atrial-ventricular defibrillator is thatthe superior vena cava electrode is already present for deliveringshocks to halt ventricular arrhythmias. Possible lead configurationsusing the electrode in the superior vena cava are shown in FIGS. 17-18.As illustrated in FIG. 17, such an embodiment may comprise a firstcatheter 315 carrying a right atrium electrode 311, a coronary sinus oselectrode 314, and a distal coronary sinus electrode 313 as describedabove, and a second cathter or lead 316 carrying a superior vena cavaelectrode 312 and an optional right ventricle electrode 317 (which maybe used for atrial or ventricular defibrillation). Still anotherembodiment, as illustrated in FIG. 18, an embodiment may comprise afirst catheter 325 carrying a coronary sinus os electrode 324 and adistal coronary sinus electrode 323 as described above, a secondcatheter or lead 326 carrying a superior vena cava electrode 322 and anoptional right ventricle electrode 327 (which may be used for atrial orventricular defibrillation), and a third catheter or lead 328 carrying aright atrial electrode 321 (which third catheter 328 may or may not beattached to first catheter 325 in the manner described in connectionwith FIG. 10 above). One preferred embodiment of the shocks would beright atrium to distal coronary sinus, followed by superior vena cava tocoronary sinus ostium. Another configuration would be with these twoshocks in reverse sequence.

Another catheter device that may be used in carrying out the presentinvention is a flexible, two-pronged catheter 350, which may be used for(among other things) situating electrodes such as defibrillationelectrodes in the right atrium, the coronary sinus, and along the rightside of the atrial septum (or Bachmann's bundle). The device,schematically illustrated in FIG. 19, is comprised of a primary catheterbody 351 that has lead body (preferably coil) electrodes 352, 353, 354;the distal electrode 354 may be used for situation or insertion into thecoronary sinus, and the proximal electrode 352 may be used for situationin the right atrijum. The electrode 353 (SP) carried by an appendagecatheter body 360 connected to the primary catheter body 351, may beused for situation along the right side of the atrial septum orBachmann's bundle, and is connected to the primary catheter body midportion, preferably between the electrodes 352, 354, and in oneembodiment approximately half way between electrodes 352 and 354. ThisSP electrode may take one of several forms. The appendage catheter body360 is connected to the primary catheter body 351, at a junction portion362 that has a memory and corresponding elasticity such that the angle363 between the primary catheter body 351 and the appendage catheterbody 353 is about 30, 50 or 70 to 120, 140 or 160 (most preferably about90) degrees off of the primary catheter body. But, the elongateconnector has elasticity at its cfonnection portion with the primarycatheter such that the SP electrode may be bent back in line(substantially parallel) with the primary catheter. In this manner, theSP electrode may be bent along the primary catheter for transvenoussituation of the catyheter system into the heart, for example byinsertion through an introducer tube or guide. For extraction, the SPelongate member may also be elastically bent back in the oppositedirection along the axis of the primary catheter toward the CSelectrode.

The SP electrode may take one of several forms. A simple embodiment is alead-body coil electrode, as found in ICD lead-body defibrillationelectrodes. In this embodiment the inner diameter of the introducerrequired to situate the catheter system must be equal to at least thesum of the diameters of the SP coil and primary catheter. In analternate embodiment, the SP electrode may be a relatively flat meshelectrode. This flat mesh electrode may be of a length as desired (e.g.,1 to 6 cm). Its width may be up to (for example) the circumference ofthe primary catheter. Being pliable, during placement of the cathetersystem, the SP electrode may be bent back over the proximal side of theprimary catheter, and the SP electrode may be “wrapped” around theprimary catheter, thereby requiring an introduce with an inner diameterthat is not substantially greater than that which would be employedwithout the SP member.

While the connecting portion of the SP member attchement to the primarycatheter has elasticity, the primary catheter body has rotationalstiffness so that, once in the general vicinty, the prximal end of thecatheter may be rotated to optimize the position of the SP electrode.Further, the material connecting the SP elongate member to the primarycatheter may be made of a memory alloy, polymer, or composite thereof,or the like, such that it maintains the desired angle as noted aboverelative to the long axis of the primary catheter. Also, an optionalpacing tip electrode 364 may be placed at the tip of the SP elongatemember, so that the pacing of the atrial septum or Bachmann's Bundle maybe performed.

The present invention may be implemented in combination with, oremploying the features of, numerous additional methods and systems forthe defibrillation and cardioversion of a patient's heart, including butnot limited to those disclosed in U.S. Pat. No. 6,006,131 to Cooper etal.; U.S. Pat. No. 6,002,962 to Huang et al.; U.S. Pat. No. 5,987,354 toCooper et al.; U.S. Pat. No. 5,978,705 to Ideker et al.; U.S. Pat. No.5,978,704 to Ideker et al. U.S. Pat. No. 5,509,925 to Adams; U.S. Pat.No. 5,630,834 to Bardy; and U.S. Pat. No. 5,476,499 to Hirschberg. Thedisclosures of all U.S. Patent references cited herein are to beincorporated herein by reference in their entirety.

The present invention is further illustrated in the experimentalexamples set forth below.

EXAMPLES Reduction of Atrial Defibrillation Threshold With anInteratrial Septal Electrode

This example demonstrates that an electrode configuration with aninteratrial septal electrode placed approximately midway between theright atrial appendage and coronary sinus electrodes increases thepotential gradient in this region and thus lowers the atrialdefibrillation threshold (ADFT).

I. METHODS

All studies were performed in accordance with the guidelines establishedin the Position of the American Heart Association on Research Animal Useadopted by the American Heart Association on Nov. 11, 1984.

Of 11 adult sheep, 8 (41±6 kg, heart mass 217±8 g) completed theexperimental protocol; only data from these 8 animals were compiled.

Animal Preparation. As a preanesthetic agent, a 1-to-1 mixture oftiletamine and zolazepam (8-10 mg/kg) was given intramuscularly. About10 minutes later, thiopental (2-6 mg/kg) was administered as a slowintravenous bolus. The animal was laid in a dorsally recumbent positionon a fluoroscopy table, intubated, and placed on a volume-cycledventilator (tidal volume: 15-20 ml/kg) with a 4% isoflurane/oxygenmixture at a rate of 8-12 breaths per minute. The isofluraneconcentration was decreased to 1.5-3.5% to maintain a deep surgicalplane of anesthesia. Ventilator settings were adjusted as necessary tocorrect for respiratory acidosis or hypoxemia. Intravenous fluids(Lactated Ringer's solution) were infused throughout the experiment withsupplemental electrolytes as needed as determined by serial blood gasand chemistry analyses conducted every 30-60 minutes.

An 8 Fr. sheath was placed in the left femoral artery percutaneously forcontinuous arterial pressure monitoring. The animal was instrumented forlead II ECG and esophageal temperature monitoring. A heated waterblanket was used to maintain body temperature at 37±1° C. Neuromuscularblockade was achieved with a 1 mg/kg succinylcholine chlorideintravenous bolus followed by an intravenous drip (5-8 mg/min) formaintenance, depending upon neuromuscular tone. At all times, anexternal defibrillator with external paddles was available in the eventof non-perfusing ventricular tachyarrhythmia.

Defibrillation Catheter Placement. All catheters were positionedtransvenously under fluoroscopic guidance. Through a jugular vein, adefibrillation lead (Perimeter #7109, Guidant Corp., St. Paul, Min.)with a distal 6-cm long electrode was situated with its coil electrodein the distal coronary sinus (CS) along the left lateral heart and itstip under the left atrial appendage. Care was taken to not place thislead in the persistent superior vena cava, which is present in thisspecies. A modified quadripolar catheter (Mansfield EP-Boston ScientificCorp., Watertown, Mass.) with a 3.5-cm-long coil electrode 1 cm proximalto the catheter tip was positioned in the right atrial appendage (RAA)through the left femoral vein. The coil electrode was laid along thesuperior wall of the RAA. The bipolar tip of this catheter was used forthe burst-pacing induction of AF. Another two 3.5-cm-long coil electrodecatheters were also placed in the main and left pulmonary artery (PA)and lower right atrium (LRA), respectively. The LRA electrode waspositioned at the junction of right atrium and inferior vena cava.

A custom-made 6-cm coil electrode that served as the interatrial septalelectrode (SP) was constructed along a catheter; the distal end of theelectrode was 3 cm from the catheter tip. It was situated through atrans-septal procedure. An 8 Fr. Mullins sheath was advanced into theright atrium through the right femoral vein over a 0.038″ guide wire.Then, a Brockenbrough needle replaced the guide wire and was displacedthrough the atrial septum, usually under LAO projection. Confirmation ofleft atrial catheterization was made by measurement of oxygen saturationof blood withdrawn through the Brockenbrough needle and with contrastinjection into the left atrium during fluoroscopy. A stiff 0.038″ guidewire was positioned in the left atrium through the sheath. The Mullinssheath was then withdrawn over the wire, leaving the wire in the leftatrium. Next, an 11 Fr. guide sheath was advanced over the wire and intothe left atrium. After withdrawal of the dilator and guide wire, theseptal electrode was inserted into the left atrium through the guidesheath. The tip of the septal electrode catheter was placed against thelateral wall of left atrial appendage. About ⅔ of the electrode was inthe left atrium and ⅓ in the right atrium. After the septal electrodewas in position, 1000 units of heparin were given intravenously everyhour.

Additionally, a three-electrode defibrillation catheter (Endotak DSP,Guidant Corp., St. Paul, Min.) was introduced into the right ventriclethrough the other jugular vein; the two lead-body coil electrodes fromthis catheter were situated in the right ventricle (RV) and superiorvena cava (SVC). The tip electrode from this catheter was used forventricular pacing. A three-wire subcutaneous array (SQA) was insertedover the left side of the heart. In the event of ventriculartachyarrhythmias, the electrode configuration for ventriculardefibrillation was RV as the first phase anode with CS, SVC and SQAelectrically common as the first phase cathode (RV→CS+SVC+SQA).

Induction of Atrial Fibrillation. To allow AF to be maintained,acetyl-β-methylcholine chloride (Sigma Chemicals Co., St Louis, Mo.) wascontinuously infused into the pericardium. The pericardial space wasapproached percutaneously under fluoroscopic guidance with a 3-inch-long16-gauge needle from just inferior to the right subxiphoid position withthe animal turned about 20 degrees toward the right side. When theneedle was confirmed to be within the pericardial space by contrastinjection, a guide wire was gently inserted within the needle into thepericardial space. The pericardial location for the guide wire wasconfirmed by inability to move it outside the fluoroscopic image of theheart silhouette. After removal of the needle, a 6 Fr. sheath wasadvanced into the pericardial space over the wire. After flushing withacetyl-β-methylcholine chloride, a 4 Fr. pig-tail catheter was insertedthrough the sheath. Typically, the catheter tip was advanced to near theleft atrial appendage and the sheath was removed.

Acetyl-β-methylcholine chloride solution (1 g/250 ml saline) was infusedat a rate of 20 μL/min using a micro-infuser. Burst pacing used toinduce AF consisted of 2-ms stimuli delivered at intervals of 30-60 ms.AF was defined as irregular rapid atrial activity with an irregularventricular response on the ECG. Blood pressure and heart rate wererecorded before and 20 min after acetyl-β-methylcholine infusion.

Defibrillation Waveforms and Lead Configurations. Onceacetyl-β-methylcholine chloride was infused long enough to support AFmaintenance of >10 minutes (typically ˜20 minutes), the defibrillationprotocol was begun. The waveform generation system has been describedpreviously (R. Cooper et al., Circulation. 1997;96:2693-2700). Briefly,a monophasic waveform was produced by a programmable defibrillator(HVS-02, Ventritex, Inc). This monophasic waveform was divided into abiphasic, truncated-exponential waveform by a high-voltage, cross-pointswitch; for sequential shocks, two biphasic, truncated-exponentialwaveforms were created with the use of an additional pair of cross-pointswitches. Each biphasic waveform had a first-phase duration of 3 ms anda second-phase duration of 1 ms. The interval between each phase of thebiphasic waveforms and between the two biphasic waveforms of sequentialshocks was 20 μsec. Because all stimuli (single or sequential shocks)were produced from the output of one defibrillator, all phases of thewaveforms exhibited decaying voltage from a single capacitor, in whichthe trailing-edge voltage of each preceding phase was equal to theleading-edge voltage of the succeeding phase.

In each animal, the ADFTs of five test configurations were determined(Table 1). Three configurations utilizing the septal electrode werenamed A1, A2 and A3. The two others were named B and C, respectively.The order of determining the test-configuration ADFTs was randomized ineach animal as follows. The order among A, B and C was initiallyrandomized, and then the order of A1, A2 and A3 (within A) wasrandomized. The ADFTs of the configurations utilizing the septalelectrode were measured consecutively in order to obviate the need forrepositioning this electrode. During the ADFT testing of anyconfiguration, passive electrodes not delivering any shock for thatconfiguration were removed. To minimize the likelihood of ventriculartachyarrhythmia induction, shock delivery was synchronized toright-ventricular pacing, which triggered the Ventritex defibrillatorand cross-point switches via custom software on a Macintosh Computer.The cycle length of this pacing was 250-400 ms, depending on theventricular rate during AF. Shocks were delivered 20 ms after the 8^(th)pacing pulse.

TABLE 1 Test Configurations First Shock Second Shock Biphasic AnodeCathode Anode Cathode Waveform A1 RAA + CS SP Single A2 RAA SP CS SPSequential A3 CS SP RAA SP Sequential B RAA CS Single C RAA CS LRA PASequential RAA: right atrial appendage, CS: coronary sinus, SP: atrialseptum, LRA: low right atrium, PA: pulmonary artery.

The ADFT of each test configuration was determined using amultiple-reversal method with an initial starting peak voltage of 100 Vand step sizes of 40/20/10 V. If the initial shock failed, the next andsubsequent shock voltages were increased by 40 V until a shocksucceeded. Following the first shock that successfully terminated AF,the voltages of subsequent shocks were decreased by 20 V until a shockfailed. Then the shock voltages were increased by 10 V until a shocksucceeded again. Conversely, if the initial shock succeeded, subsequentshock voltages were decreased by 40 V until a shock failed. Then shockvoltages were increased by 20 V until a shock succeeded, after whichshock voltages were decreased by 10 V until a shock failed again. Thelast successful shock of the third reversal was deemed the ADFT of thetest configuration. Before starting the defibrillation protocol, 3-5test shocks were given. All test shocks were delivered after inducing AFand allowing it to be sustained 1 minute. When a test shock failed, arescue shock of 200-300 V was given. A 1-2 min period of sinus rhythmwas allowed before the next induction of AF.

Data Acquisition. The leading-edge (peak) voltage and current of eachtest shock were recorded, and the impedance and delivered energy of eachshock were computed by a waveform analyzer (DATA 6100, Data Precision).

Postmortem Examination. After the completion of data collection,euthanasia was induced with an intravenous bolus of potassium chloride.The chest was opened and the location of the electrodes of the last testconfiguration was confirmed by palpation through the heart walls. Theheart was then removed. The great vessels were trimmed to the point ofinsertion into each cardiac chamber, and the pericardium was removed.The mass of the heart was determined.

Statistical Analysis. Results are expressed as the mean±SD. The overalleffect of the 5 test configurations on each ADFT characteristic wastested by repeated-measures ANOVA. Pair-wise differences in measuresbetween the 5 configurations were tested by paired t tests. A value ofP<0.05 was considered significant.

II. RESULTS

Reproducible, sustained AF could be induced in all animals. Theventricular rate in sinus rhythm before and 20 min after administrationof acetyl-β-methylcholine was similar (112±8 vs. 109±11 beat/min,respectively, P=NS). The drug significantly lowered the sinus-rhythmsystolic/diastolic blood pressure, however (107±8/83±4 vs. 84±7/62±5mmHg, P<0.05). During AF, the ventricular rate varied from 80 to 178beat/min (131±36 beat/min). After successful test shocks, sinus rhythmusually recovered quickly (<1.5 sec). In 1 sheep with a long sinusrecovery time (>2-4 sec), temporary post-shock atrial pacing wasperformed.

Leading Edge Voltage. The ADFT leading-edge-voltage of the 5configurations is shown in FIG. 13. The ADFT leading-edge-voltage ofconfiguration A2 (RAA→SP/CS→SP; 71±16 V) was significantly lower thaneach of the other 4 configurations (A1: 102±36 V; A3: 121±34 V; B:156±38 V; and C: 96±29 V). The ADFT leading-edge-voltage ofconfiguration B (RAA→CS) was significantly higher than the other 4configurations.

Leading Edge Current. The ADFT leading-edge-current is shown in FIG. 14.The ADFT leading-edge-current of configuration A2 (1.68±0.48 A) wassignificantly lower than that of the other 4 configurations A1, A3, Band C (A1: 4.32±1.59 A; A3: 3.61±1.28 A; B: 2.99±1 A; and C: 1.92±0.65A). The ADFT leading-edge-current of configuration C was lower than thatof configurations A3 and B. The leading-edge-current ADFT ofconfiguration A1, which was the sum of the currents of two pathways:RAA→SP and CS→SP, was higher than that of configurations A2, B and C butnot configuration A3.

Impedance. The impedances of the test configurations are shown in Table2. Impedances of the same pathway in different test configurations werenot significantly different. Configuration A1 exhibited the lowestimpedance, which was approximately the reciprocal of the sum of thereciprocal impedances of its two pathways (RAA→SP and CS→SP) asestimated from individual shocks across these pathways during sequentialshocks.

Shock Energy. The ADFT shock-energy of the 5 configurations is shown inFIG. 15. Configuration A2 had a significantly lower ADFT shock-energythan each of the other 4 test configurations (A2: 0.39±0.17 J vs. A1:0.86±0.59 J, A3: 1.16±0.72 J, B: 1.27±0.67 J, and C: 0.68±0.46 J; P<0.05for each comparison). The ADFT shock-energy of configuration A2 waslower than that of configurations A1, A3, B and C by 46±20%, 63±14%,68±8%, and 36±15%, respectively. Configuration C had a lower ADFTshock-energy than configurations A1, A3 and B (P<0.05 for eachcomparison). Compared with configuration B, configuration C reducedshock energy by 50±9%. Configuration A1 had a lower ADFT shock-energythan configuration B (37±15% lower, P<0.05), but not than configurationA3. The difference in ADFT shock-energy between configurations A3 and Bwas not significant.

TABLE 2 Impedances of all the current pathways Current PathwaysImpedance(Ω) A1 Single RAA + CS → SP 25 ± 3 A2 First RAA → SP 46 ± 3Second CS → SP 34 ± 4 A3 First CS → SP 35 ± 4 Second RAA → SP 45 ± 4 BSingle RAA → CS 54 ± 6 C First RAA → CS 54 ± 7 Second LRA → PA 49 ± 4RAA: right atrial appendage, CS: coronary sinus, SP: atrial septum, LRA:low right atrium, PA: pulmonary artery.

While care must be used in directly extrapolating the results of thisstudy to humans because of the particular pharmaceutical interventionsemployed. Nevertheless, this study demonstrates that, in an acute sheepmodel of sustained AF, atrial defibrillation configurations utilizing anadditional electrode at the interatrial septum were more efficaciousthan the present standard configuration by which cardioversion isachieved with RAA→CS. The ADFT shock-energy of RAA+CS→SP was 37±15%lower, and sequential shock configuration RAA→SP/CS→SP was 68±8% lowerthan that of RAA→CS.

The foregoing is illustrative of the present invention, and is not to beconstrued as limiting thereof. The invention is defined by the followingclaims, with equivalents of the claims to be included therein.

That which is claimed is:
 1. An implantable system for thedefibrillation of the atria of a patient's heart, said systemcomprising: a first atrial defibrillation electrode configured forstimulating Bachmann's bundle and for positioning on or adjacentBachmann's bundle along the superior aspect of the atrium and adjacentto the atrial septum; a second atrial defibrillation electrode whichtogether with said first atrial defibrillation electrode provides a pairof atrial defibrillation electrodes; and a pulse generator operativelyassociated with said pair of atrial defibrillation electrodes fordelivering an atrial defibrillation pulse.
 2. The implantable systemaccording to claim 1, wherein said first atrial defibrillation electrodeis carried by a first catheter, said first catheter configured forinsertion into the right atrium of said heart without extending into theright ventricle of said heart.
 3. An implantable system according toclaim 1, wherein the electrode is configured to be positioned within atrans-septal puncture in the atrial septum or in Bachmann's bundle. 4.An implantable system according to claim 1, wherein said first atrialdefibrillation electrode is carried by a first catheter, said firstcatheter has a distal end portion and a terminal screw connected to thedistal end portion, whereby said first electrode may be fixed to saidatrial septum or Bachmann's bundle with said terminal screw.
 5. Animplantable system according to claim 1, wherein said first atrialdefibrillation electrode is carried by a first catheter, and said firstcatheter has a distal end portion and a retractable hook connected tosaid distal end portion, whereby said first electrode may be fixed tothe atrial septum or Bachmann's bundle with said hook.
 6. An implantablesystem according to claim 1, wherein said first atrial defibrillationelectrode is carried by a first catheter, said first catheter having adistal end portion and an expandable member connected to said distal endportion, with said first electrode connected to said expandable member.7. An implantable system according to claim 1, further comprising afirst catheter configured for carrying the first atrial defibrillationelectrode and a second catheter configured for insertion through thecoronary sinus and into a vein on the surface of the left ventricle ofthe heart, wherein said second electrode is connected to the secondcatheter.
 8. An implantable system according to claim 1, furthercomprising an implantable housing having an external surface portion,with said pulse generator contained within the housing, and with thesecond electrode connected to the external surface portion of thehousing.
 9. A method for the defibrillation of the atria of a patient'sheart, said method comprising: positioning a first atrial defibrillationelectrode on or adjacent Bachmann's bundle along the superior aspect ofthe atrium and in or adjacent to the atrial septum for stimulatingBachmann's bundle; positioning a second atrial defibrillation electrodeto provide a pair of atrial defibrillation electrodes together with saidfirst atrial defibrillation electrode; and administering an atrialdefibrillation pulse through said pair of atrial defibrillationelectrodes.
 10. The method according to claim 9, wherein said firstatrial defibrillation electrode is carried by a first catheter, and saidfirst catheter is inserted into the right atrium of said heart withoutextending into the right ventricle of said heart.
 11. The methodaccording to claim 9, wherein the said first atrial defibrillationelectrode is positioned within a trans-septal puncture in the atrialseptum or in Bachmann's bundle.
 12. The method according to claim 9,wherein said first atrial defibrillation electrode is carried by a firstcatheter, said first catheter has a distal end portion and a terminalscrew connected to the distal end portion, and said first atrialdefibrillation electrode is fixed to the atrial septum with saidterminal screw.
 13. The method according to claim 9, said first atrialdefibrillation electrode is carried by a first catheter, and said firstcatheter has a distal end portion and a retractable hook connected tosaid distal end portion, and said first atrial defibrillation electrodeis fixed to the atrial septum or Bachmann's bundle with said hook. 14.The method according to claim 9, said first atrial defibrillationelectrode is carried by a first catheter, said first catheter having adistal end portion and an expandable member connected to said distal endportion, with said first electrode connected to said expandable member,and said first atrial defibrillation electrode is positioned byexpanding said expandable member.
 15. The method according to claim 9,wherein said first atrial defibrillation electrode is carried by a firstcatheter, the method further comprising inserting a second catheterthrough the coronary sinus and into a vein on the surface of the leftventricle of the heart, wherein said second electrode is connected tosaid second catheter.
 16. The method according to claim 9, wherein firstsaid atrial inserting a first catheter and a second catheter carryingsaid pair of atrial defibrillation electrodes into the patient, withsaid first catheter connected to said second catheter inside the heart.17. The method according to claim 16, wherein said second catheter ispositioned in the right ventricle or coronary sinus of said heart. 18.An implantable system for the defibrillation of the atria of a patient'sheart, said system comprising: a first catheter carrying a first atrialdefibrillation electrode configured for stimulating Bachmann's bundleand for positioning on or adjacent Bachmann's bundle along the superioraspect of the atrium and adjacent to the atrial septum; a secondcatheter connected to said first catheter at a junction configured forplacement inside the heart, the second catheter carrying a second atrialdefibrillation electrode which together with said first atrialdefibrillation electrode provides a pair of atrial defibrillationelectrodes; and a pulse generator operatively associated with said pairof atrial defibrillation electrodes for delivering an atrialdefibrillation pulse.
 19. An implantable system according to claim 18,wherein said second catheter is configured for positioning in the rightventricle or coronary sinus of said heart.
 20. Method for thedefibrillation of the atria of a patient's heart, said methodcomprising: inserting a first catheter carrying a first atrialdefibrillation electrode and a second catheter carrying a second atrialdefibrillation electrode into the heart, with said first catheterconnected to said second catheter at a junction inside the heart andsaid first atrial defibrillation electrode and said second atrialdefibrillation electrode together providing a pair of atrialdefibrillation electrodes; positioning the first atrial defibrillationelectrode on or adjacent Bachmann's bundle along the superior aspect ofthe atrium and in or adjacent to the atrial septum for stimulatingBachmann's bundle; and administering an atrial defibrillation pulsethrough said pair of atrial defibrillation electrodes.
 21. The methodaccording to claim 20, further comprising inserting the second catheterthrough the coronary sinus and into a vein on the surface of the leftventricle of the heart.
 22. The method according to claim 20, whereinsaid second catheter is positioned in the right ventricle or coronarysinus of said heart.